CClinicalTrials.gg
Status unknownNCT04518202Updated Aug 19, 2020

Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy

An interventional study of lidocaine patch and Sham patch in Infertility, Female, sponsored by Aswan University Hospital. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-08-19.

Sponsored by Aswan University Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Female
01

Study summary

To compare the effectiveness of Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy

Read the detailed description

hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, fibroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body. Cervical ripening is made possible by the use of medication through different routes.

02

Conditions studied

  • Infertility, Female
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 200 is above the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Aswan University Hospital is the lead sponsor of 95 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • patients with an indication for office hysteroscopy

Exclusion criteria

Exclusion Criteria:

  • patient refuse to participant
  • contraindication for lidocaine patch
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    lidocaine patch

    5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy.

    Drug: lidocaine patch

  • Placebo comparator
    Sham patch

    Sham patch applied at 6 hours before the scheduled office hysteroscopy.

    Drug: Sham patch

Interventions

  • Druglidocaine patch

    5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy.

    Also known as: Experimental

  • DrugSham patch

    Sham patch containing no study medication applied at 6 hours before the scheduled office hysteroscopy.

    Also known as: Placebo Comparator

06

What researchers measure

Primary outcomes

  1. Pain intensity will be assessed by visual analogue scale

    Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure. Visual analogue scale ranging from 0 to 10

    Time frame: 10 minutes

Secondary outcomes

  1. Operative time

    From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination

    Time frame: 15 minutes

07

Study locations

1 site
  • Aswan University Hospital
    Aswan, 81528, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04518202
Lead sponsor
Aswan University Hospital
Responsible party
hany farouk (A Professor, Aswan University Hospital) — Principal investigator
First posted
Aug 19, 2020
Start date
Sep 1, 2020 (estimated)
Primary completion
Aug 31, 2021 (estimated)
Completion
Sep 30, 2021 (estimated)
Last update
Aug 19, 2020

Study contacts

hany f Sallam, md
Contact
hany.farouk@aswu.edu.eg
+20102435461 ext. 002
nahla w Shady, md
Contact
hanygyne@yahoo.com
+201022336052 ext. 002
nahla w Shady, md
study chair · Aswan universirty

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion